ZUK E0015899-8

GUDID 00885556717264

RT 5-6 UNI TIBIA SIZER AND DRILL GUIDE

Smith & Nephew, Inc.

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Primary Device ID00885556717264
NIH Device Record Key20179950-383f-4914-a85c-773956a8b726
Commercial Distribution StatusIn Commercial Distribution
Brand NameZUK
Version Model NumberE0015899-8
Catalog NumberE0015899-8
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556717264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


[00885556717264]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2018-03-29

On-Brand Devices [ZUK]

00885556731475ZUK SPACER BLOCK 11MM
00885556731468ZUK SPCER BLOCK 9MM
00885556728871ZUK SPACER BLOCK - 9MM
00885556728864ZUK SPACER BLOCK - 11MM
00885556717264RT 5-6 UNI TIBIA SIZER AND DRILL GUIDE
00885556717257RT 3-4 UNI TIBIA SIZER AND DRILL GUIDE
00885556717240RT 1-2 UNI TIBIA SIZER AND DRILL GUIDE
00885556717233LT 5-6 UNI TIBIA SIZER AND DRILL GUIDE
00885556717226LT 3-4 UNI TIBIA SIZER AND DRILL GUIDE
00885556717219LT 1-2 UNI TIBIA SIZER AND DRILL GUIDE
00885556717202RT UNI TIBIA KEEL PUNCH
00885556717196LT UNI TIBIA KEEL PUNCH
00885556716113ZUK SPACER BLOCK - 11MM
00885556716106ZUK SPACER BLOCK - 9MM
00885556689813ZUK FEMORAL/TIBIAL COMBINED SIZER LL/RM
00885556689806ZUK FEMORAL/TIBIAL COMBINED SIZER LM/RL
00885556689790ZUK TIBIAL SIZING TEMPLATE SZ 6
00885556689783ZUK TIBIAL SIZING TEMPLATE SZ 5
00885556689769ZUK TIBIAL SIZING TEMPLATE SZ 3
00885556689752ZUK TIBIAL SIZING TEMPLATE SZ 2
00885556689745ZUK TIBIAL SIZING TEMPLATE SZ 1
00885556689707ZUK SPACER BLOCK - 11MM
00885556689691ZUK SPACER BLOCK - 9MM
00885556689639ZUK SPACER BLOCK - 9MM
00885556658222SMITH AND NEPHEWS ZUK TRAY LID
00885556658215TIBIA INSTRUMENT AND TRIAL TRAY
00885556658208TIBIA INSTRUMENT TRAY
00885556658192FEMORAL INSTRUMENT TRAY
00885556657744ZUK SPACER BLOCK - 9MM
00885556657737ZUK SPACER BLOCK - 11MM
00885556657720ZUK SPACER BLOCK - 11MM
00885556657713ZUK SPACER BLOCK - 9MM
00885556621813Long Headless Smooth Pin Gold
00885556621806ZUK Ankle Clamp
20885556621794MIS Z Retractor
00885556621783MIS Small PCL Retractor
00885556621776MIS Quad-Sparing Screw Inserter Extractor
00885556621769MIS Quad-Sparing Headed Screw 48 MM Length
00885556621752MIS Quad-Sparing Headed Screw 33 MM Length
00885556621745Tibial Resection Guide
20885556621732ZUK Short Headed Holding Pin 17mm
20885556621725ZUK Short Headed Holding Pin
20885556621718ZUK Short Headed Holding Pin 52mm
00885556621691Headless Trocar Drill Pin 3.2 MM Diameter 75 MM Length
008855566216842MM FEMORAL/TIBIAL RECUTTER
00885556621677ZUK Insertion Handle
00885556621660Tray/Articular Surface Inserter Tip
00885556621653ZUK Articular Surface Inserter Handle
00885556621646Zimmer Unicompartmental Femoral Reamer .270
00885556621639Tibial Sizing Slider

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